David Franklin Vs. Parke-Davis Court Case

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The court case I have chosen to examine is David Franklin versus Parke-Davis, which was a landmark lawsuit that ultimately ended up setting the precedence for future lawsuits against pharmaceutical companies for off-label promotion using the False Claims Act set forth in the Food, Drug and Cosmetic Act of 1938 (FDCA). David Franklin was PHD level scientist who was employed by Parke-Davis as a medical liaison in 1996. The parent company for Parke-Davis at the time was the Warner-Lambert Company in which Park-Davis was responsible for the pharmaceutical products division that included the manufacturing, marketing and research and development for novel medications and therapies. During Franklin’s short tenure at Parke-Davis, he claimed that …show more content…

The term qui tam is used as a writ in which a private citizen who assists in the prosecution is entitled to receive a portion of any monetary penalties levied . This also allows a private individual, termed “whistle-blower”, to use the False Claims Act (FCA) to present fraud perpetrated against the federal government3. The purpose of the lawsuit entered by Franklin would ultimately seek retribution to the United States for the millions of dollars spent by Medicaid for the medication Neurontin that was prescribed by physicians under fraudulent …show more content…

Firstly, this case marked the inaugural lawsuit brought against a pharmaceutical company for using off-label marketing tactics utilizing the False Claims Act as the legal framework. The use of the FCA would pave the way for a multitude of future lawsuits involving off-labeling techniques used by large pharmaceutical companies along with citing kickbacks paid to physicians (quid pro quo) for prescribing the medication to patients, with special incentives given to physicians writing the most prescriptions. The second reason it was important is because up to that date, it was the largest settlement awarded as well as one of the highest awarded to a private individual for his role in exposing the fraud perpetrated by his employer. The whistle-blower categorization would now be able to provide private citizens with major portions of large settlements, thus providing monetary incentive for employees to come forward with information that could expose fraudulent business practices perpetrated by large corporations. This ruling also made a clear precedent that the FDCA of 1938 could be used in conjunction with the Medicaid and Medicare fraud abuse laws to levy civil and criminal offenses against pharmaceuticals companies for engaging in unethical marketing practices using indications for a medication not approved by the FDA. One of the biggest atrocities perpetrated in this case, which cannot be

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